How An Ethically Challenged Researcher Found A Home at the University of Miami

Three weeks ago, the National Institutes of Health announced new rules to govern federally-funded researchers and their financial conflicts of interest. Three years in the making, the policy will affect over 38,000 scientists at 2000 organizations as the NIH attempts to ensure that biomedical research, paid with taxpayer dollars, remains objective.

But none of these changes might have happened were it not for Dr. Charles Nemeroff.

A renowned chairman of psychiatry at Emory University, Nemeroff was a proponent for drugs sold by GlaxoSmithKline, such as the antidepressant Paxil. While earning hundreds of thousands of dollars jetting around the country and giving talks about Paxil to doctors at fancy restaurants, Nemeroff also managed a multi-million dollar grant from the NIH to research drugs under development by Glaxo.

The ensuing scandal became central to an investigation by Senator Charles Grassley into undisclosed payments from companies to prominent physicians—a practice that puts patients at risk and drives up healthcare costs. As Grassley’s lead investigator on the matter, I had a ringside seat as arguably the most powerful psychiatrist in the country was forced from prominence, eventually leaving Emory.

At my new job with the Project On Government Oversight (POGO), a government watchdog, I have continued to study the cozy relationships between physicians and corporations. I also observed as Nemeroff left Emory for a new job at the University of Miami which has a medical school operating under financial strain. But why would this school snatch up a physician with such a history?

According to new emails and other materials shown to me, UM officials had serious concerns about Nemeroff’s history of ethical blunders. However, these emails suggest that Nemeroff’s perceived ability to raise money trumped those concerns. At one point while negotiating with UM for a job, Nemeroff even dangled the possibility of a new funder for the school if he was hired. These emails imply that, despite new federal rules, the public must remain vigilant to ensure that medicine is practiced with the highest regard for ethics and patient safety.

Officials at UM did not respond to detailed and repeated questions about the emails, which include communications by UM President Donna Shalala, who is now facing public scrutiny over a separate ethics scandal involving UM’s football program.

Last November POGO releaseddocuments alleging that Nemeroff and other academic physicians of putting their names on scientific publications drafted or managed by Scientific Therapeutics Information, a public relations firm retained by Glaxo. The practice is called ghostwriting, and it appears to be quite pervasive in medical research, although some universities call it a form of plagiarism.

Among the documentswemadepublic was a timeline and first draft of a book whose purported authors are Nemeroff and Alan Schatzberg, a professor at Stanford. Daniel Carlat, a psychiatrist and author, bought the book and wrote on his blog that it read like “an advertisement for Paxil. Not obvious, not blatant. But artfully crafted, subtle, smooth.”

Nemeroff denies any wrongdoing. In a statement to the Miami Herald, he characterized anychargeofghostwriting as ``blatantly false and inaccurate.''

Pascal Goldschmidt, Dean of the University of Miami’s Medical School, leaped to Dr. Nemeroff’s defense, telling the Herald:

It is unfortunate that two individuals who have contributed so much to the medical discipline of psychiatry…and to the health of so many patients with dreadful psychiatric illnesses here in the U.S. and beyond, are exposed to such an unreliable and unfounded challenge to their reputation.

To me the question is why the University of Miami is so protective of Nemeroff.

In August 2003, Melody Peterson of the The New York Times wrote that Nemeroff, chairman of psychiatry at Emory, failed to report his conflicts of interest in an article published in a medical journal.

AccordingtotheTimes, Nemeroff favorably described a lithium patch and gave kudos to products sold by Corcept Therapeutics and Cypress BioSciences. However, he did not disclose his own patent for the lithium patch nor his financial interests in the two companies.

''I have always been totally compliant, probably gone overboard, with disclosure,'' Nemeroff told the Times. ''If there is a fault here, it is with the journal's policy.''

A second incident happened in July, 2006, when the Wall Street Journal wrote about a journal article praising Cyberonics’ treatment for depression. Accordingtotheexecutivedirector of the medical society that publishes the journal, Nemeroff and his colleagues didn't disclose their financial ties to Cyberonics in the manuscript they submitted to the journal as required.

Dr. Nemeroff told the Journal that there was "no intent whatsoever on my part or any of my co-authors to hide the fact we were working in collaboration with Cyberonics."

And that was that, until October, 2008, when Nemeroff landedonthefrontpageoftheNewYorkTimes, in a story charging that he had failed to report over a million dollars in payments from various companies including GlaxoSmithKline.

Written by Gardiner Harris, the story was based on internal Emory documents made public by Senator Grassley. The story also reported on a GlaxoSmithKline spreadsheet detailing dozensofmarketingtalks that Dr. Nemeroff gave to push Glaxo’s drugs to doctors.

The story noted:

In one telling example, Dr. Nemeroff signed a letter dated July 15, 2004, promising Emory administrators that he would earn less than $10,000 a year from GlaxoSmithKline to comply with federal rules. But on that day, he was at the Four Seasons Resort in Jackson Hole, Wyo., earning $3,000 of what would become $170,000 in income that year from that company — 17 times the figure he had agreed on.

As the story broke, Emoryannounced that Nemeroff was stepping down as chairman but would remain on faculty in the psychiatry department. The National Institutes of Health alsosuspended one of Nemeroff’s grants.

At the end of 2008, Emory took action: Dr. Nemeroff would not be reinstated as chair nor would he be allowed to submit grants to the NIH for two years. He was expected to cooperate with any investigation and would only be allowed to serve on the boards of only four companies with compensation for each limited to $10,000 annually.

According to previously undisclosed records, Nemeroff visited Pascal Goldschmidt at UM in the summer of 2009 to negotiate a potential job. They also apparently discussed creating a new center to promote ethics in academia and industry.

“I talked about the center to Ken Goodman, co-director of the UM Ethics Programs, the center would sit under the general umbrella of the Ethics Program,” Goldschmidt wrote to Nemeroff. “Ken is intrigued by the idea and would like to meet with you during your next visit.”

On June 27, 2009, Richard Bookman, UM Vice Provost for Research, emailed Goldschmidt a link to the documents on Nemeroff that the Senate Finance Committee made public.

Goldschmidt wrote back, “I have spent a while on it and bunch of newspaper articles. The key question is why did he think it was OK to simply ignore and almost challenge the NIH rules?”

But Nemeroff sweetened the deal by letting Goldschmidt know that a potential donor had stepped forward to support the Psychiatry Department if he relocated to UM.

In an email to Nemeroff, Dr. Goldschmidt seemed barely able to control himself. “Superexciting the news about the donor! Thanks for getting us the info, I am, and I know you are, looking forward to getting beyond these issues….”

In early September, a reporter at the science journal Nature began working on a story about conflicts of interest in medicine and sent Nemeroff several questions about his ethical past. Dr. Nemeroff forwarded a draft of his response to Goldschmidt.

“Please let me know what you think,” Nemeroff wrote. “I leaned heavily on your thoughts, for which I am very grateful.”

“The answer is perfect. I found a typo now corrected. Cheers, Pascal.”

In the article, which came out on September 16, 2009, Nemeroff was quoted, "I made mistakes in the area of conflict of interest for which I am sorry and remorseful. However the mistakes I made were honest mistakes." He explained that "my actions were, in my view at the time, in keeping with my understanding of the current Emory policies.”

"I also plan to use my recent experience to help others avoid problems with conflict of interest from the lessons I have so painfully learned."

Three days after the article was published, Nemeroff emailed Miami with a list of his current and future external obligations. Under the constraints placed on him by Emory, he was only allowed to ally himself with four companies, and each could only pay him $10,000 annually. But what was once four, now apparently was five.

Novadel Pharma wanted him on their board and was paying $50,000 a year. “I would estimate time out of the office as 2-4 days per year,” Dr. Nemeroff wrote.

Cenerx was paying $20,000 for Dr. Nemeroff to sit on their Scientific Advisory Board, and AstraZeneca wanted him on their advisory board as well for another $50,000 for two in person meetings.

In his email, Dr. Nemeroff wrote, “This was reduced by my request to $10,000 this past year but I would, naturally, like to go back to the original contract.”

Dr. Nemeroff also asked to serve on the board of Mt. Cook which was low on funding, but “may be reinvented with new capital.” And PharmaNeuroboost wanted Nemeroff to chair its Scientific Advisory Board, with a compensation of $40,000 for three annual meetings.

He also noted that several other companies were asking him for one time consulting gigs. “I seek your guidance on these,” Nemeroff wrote.

Over the next week, the administration discussed ways to handle Dr. Nemeroff’s outside activities “prospectively” to include penalties for failure to comply. But by the end of the month it became clear that Dr. Nemeroff was a shoo-in for the position.

“[B]oth the [National Institute of Mental Health] and Emory have cleared him of illegal activities,” wrote William O’Neill, Miami’s Dean of Clinical Affairs. He added that Nemeroff was cleared to receive federal research funding. “His ‘wrongdoing’ consisted of a lack of reporting of substantial industry consulting fees.”

As summer gave way to fall, rumors circulated that UM was going to hire Nemeroff and had retained a public relations firm to deal with any controversy. Stories began leakingtotheblogPharmalot. But when a blogger at The Scientistwroteanotherpost, a UM employee emailed the story immediately to UM President, Donna Shalala, who had once served as Secretary of the U.S. Department of Health and Human Services.

Subject: TRUE?

Dear President Shalala,

In connection with your letter today to UM Faculty and Staff, I would like to know if this physician will be employed by UM Miller School of Medicine, and if so, why, based on his failure to disclose?

The reference to a letter concerned anemailsentbyPresidentShalala that day to the UM Community. In her email, Shalala laid out new conflicts of interest rules at UM to increase the integrity of medical research and place the school as a national leader. “That integrity is the very bedrock of our institution and the foundation for the trust that students, patients, academic colleagues, and society place in us.”

Three days later, the UM sent a pressreleaseannouncing that Dr. Nemeroff had been hired as chair of the Psychiatry Department. No mention was made of the ethical controversies clouding his past.

That same day, a former UM faculty member emailed President Shalala:

Dear President Shalala:

As a former UM faculty member, I would like to add my expression of dismay to those which you have undoubtedly already received concerning the hire of Charles Nemeroff as chair of the medical school’s Dept. of Psychiatry. While his extensive connections within the Pharma industry are no doubt an alluring asset, his seeming lack of integrity in simultaneously accepting “consulting fees” from the very company (Glaxo) whose products were the basis of an NIH grant on which he was the [Primary Investigator] is absolutely outrageous. Yet, both he and Emory knowingly treated this unethical, corrupt behavior as “business as usual”, at least until Sen. Grassley named Nemeroff as a target of his conflict-of-interest investigations and HHS launched an investigation; and Nemeroff voluntarily left Emory under this cloud.

Your “Dialogue” of Nov. 2 is an affirming statement of ethical principle, and your initiatives to implement University-wide ethical behavior are overdue and welcome. Yet, one is forced to ask the question: how can one reconcile the tenor of that statement with the immediately prior hiring of so questionable an individual to such a prominent position? Does the university not perceive that this may be seen as the worst sort of hypocrisy?

Shalala responded within minutes. “Actually yours is the only one I have received. Thanks for your views.”

Safely ensconced at his new home, in mid-December, Nemeroff emailed his contacts at PharmaNeuroboost, thanking them for meeting with him in Florida.

You will recall that thus far as chair of the SAB, I have received only $10,000 of the promised $40,000 due to the limitations I had during my affiliation with Emory University. You can, however, now go ahead and remunerate me for the remaining $30,000….

Apparently, things were moving along swimmingly. After the 2010 New Year, President Shalala emailed him, “How are things going?”

Nemeroff’s response? “Couldn’t be better. Love Miami. Leadership of the school and health system have been terrific. Suffered through the bowl game….Hope to see you soon.”